DRAFT 11/01/0104/30/02
University of Southern California
Conflict of Interest in Research:
Policy and Procedure
Date Issued: ____________________, 20012002
Authority: Lloyd Armstrong, Jr.,
Provost and
Senior Vice President for Academic Affairs
Dennis F. Dougherty
Senior Vice President for
Administration
1.0 Introduction
The University of Southern California ("USC" or the “University”) encourages its faculty, staff and students to participate in meaningful professional relationships with industrial, governmental and private partners. These partnerships are established for mutually beneficial reasons and many times produce knowledge and technology that will help to meet societal needs.
In recent years, however,
the complexities surrounding apparent and actual conflicts of interest and
commitment have increased as the number of collaborative relationships between
academia and industry has grown. While
the University strongly supports our collaborations with industrial and other
private partners, there are several key values that call for protection from
conflicts that may arise from these relationships:
Our commitment to educating students;
Our commitment to academic freedom;
Our commitment to advancing
the range and depth of knowledge and understanding of the natural world and the
human condition;
Our commitment to the safety
of patients under our care and participants in research;
Our commitment to open and
timely communication and dissemination of knowledge;
Our commitment to protect
both the appearance and actual integrity and objectivity of research,
instruction and public service; and
Our commitment to transfer
University-developed knowledge to the private sector to fulfill one of the
goals of federally funded research, by bringing the fruits of research to the
benefit of society.
Policy Objectives
The objective of this document is to provide an institutional policy that encourages the full professional development of Investigators through their research, while minimizing the risk of unacceptable behavior in potential conflict situations. This policy is intended to assist University investigators in managing real or perceived conflicts of interest.
This policy cannot regulate or eliminate all situations of conflict of interest, but is intended to enable faculty members to recognize situations that raise an appearance of impropriety and to ensure that such situations are properly reviewed and resolved. To this end, all USC faculty and staff members must disclose actual or perceived conflicts so that they can be managed appropriately. Disclosure will not necessarily restrict or preclude an individual’s activities. Indeed, the problem is rarely a particular conflict itself – rather it is the question about what is done with conflict. In most cases, problems arise when the conflict is not made apparent, or when it is not assessed or managed.
Conflict of interest includes non-financial as well as financial conflicts, because non-financial interests can come into conflict with a researcher's primary commitment to maintain scientific objectivity just as financial interests may.
In compliance with federal regulations that became
effective on October 1, 1995, the University requires investigators applying to
the Public Health Service (PHS) or the National Science Foundation (NSF) for
funding to disclose in writing any significant financial interests related to
that proposal. This policy also covers all apparent and actual conflicts of
interest or commitment related to research, regardless of the funding sources
of the project. Accordingly, all research will be treated the same, regardless of
funding source, and will be managed by this conflict of interest policy.
This policy supersedes the University of Southern
California Conflict of Interest in Research: Policy and Procedures, dated
September 20, 1995.
Links to relevant policies, regulations and other
resources related to this policy are included in Section 7.0 of this policy.
2.0 Scope
This policy applies to all University faculty
members (including part-time and visiting faculty), staff and other employees,
(such as postdoctoral scholars) and students (including postdoctoral fellows
and graduate students) who propose, conduct or report research on behalf of the
University, regardless of funding source.
This policy applies to all sponsored projects, including government and
non-government funded projects (such as industry or foundation sponsors),
clinical trials and also to unfunded research projects (such as departmental or
school funded projects).
3.0 Definitions
3.1 Conflict of Interest
The term "conflict of
interest" in this policy refers to situations in which financial or other
personal considerations compromise, or have the appearance of directly and
significantly compromising an individual's professional judgment in proposing,
conducting or reporting research. The
bias caused by such conflicts may affect collection, analysis, and
interpretation of data, hiring of staff, procurement of materials, sharing of
results, choice of protocol, involvement of human participants, and the use of
statistical methods.
A faculty member, staff
member or student is considered to have a conflict of interest when he or she,
or that person's Close Relation (as defined below), possesses a financial or
personal interest in an activity that involves his or her USC responsibilities
relating to research.
Investigators and other
individuals involved in research should consider not only situations that are
unacceptable, but should also consider gray areas that might involve the
appearance of conflict. The mere appearance of a conflict may be just as
serious and potentially damaging as an actual distortion of objectivity. For every situation contemplated, there will
be some variant that adds a new set of considerations. Although not an all-inclusive list, examples of apparent
or actual conflicts of interest that should be disclosed under this policy
include but are not limited to:the following:
·
Undertaking
basic or clinical research when an Investigator or Close Relation of an
Investigator has a supervisory, managerial (e.g., director, officer,
scientific, technical or advisory appointment) or ownership interest in the
research sponsor or licensee or in a company having an economic interest in the
research (e.g., producing the product under evaluation);
·
Any
equity interests (e.g., stocks, stock options or other ownership interests)
held by an Investigator or Close Relation of an Investigator in a research
sponsor or licensee or in a company having an economic interest in the
research. This does not include mutual,
pension or other funds over which the investigator does not exercise control;
·
Any
incentive payments, bonus payments or finders fees relating to the proposal,
conduct or reporting of research received or intended to be received by an
Investigator or his or her staff members, regardless of the amount of
compensation or payments received (e.g., additional payments by research
sponsors to Investigators or research staff who enroll a certain number of
participants in a project within a certain period of time);
·
Any
consultant arrangements between an Investigator or Close Relation of an
Investigator and an organization or individual having an economic interest in
the Investigator’s research, which when aggregated for an Investigator, his or
her staff members, and their respective Close Relations (as defined below) from
that particular research sponsor exceeds $10,000;
·
Accepting
gifts, gratuities or special favors from the sponsor of an Investigator’s
research, which when aggregated for an Investigator, his or her staff members,
and their respective Close Relations (as defined below) from that particular
research sponsor exceeds $10,000;
·
Accepting
honoraria, travel expense reimbursement or other reimbursements from the
sponsor of an Investigator’s research in addition to the amounts budgeted for
the project, which when aggregated for an Investigator, his or her staff
members and their Close Relations (as defined below) from that particular
research sponsor exceeds $10,000;
·
Intellectual
property rights (e.g., patents, copyrights or royalties from such rights)
obtained by an Investigator or an Investigator’s Close Relation from a research
sponsor;
·
Using
USC resources (e.g., the name or logo, facilities, personnel, equipment,
information) by an Investigator or Close Relation of an Investigator for
personal or non-USC related business (other than incidental use);
·
Using
students or USC employees to perform services for a company in which an
Investigator or Close Relation of an Investigator has an ownership interest or
from which he or she receives any type of remuneration;
·
Unauthorized
use of confidential, privileged or proprietary information obtained in
connection with one's research responsibilities;
·
Any
outside commitment that provides for intellectual or tangible property such as
patent ownership or licensing to an organization other than the University;
·
An
agreement that restricts an Investigator’s public reporting of the information
developed by an Investigator under the agreement, or the existence of the
agreement. In the case of a relationship with a commercial organization, an
Investigator must ascertain whether there are requirements for confidentiality
that might compromise his or her fundamental rights of academic freedom or
those of other faculty members, students or the University;
·
Undertaking
research that may impact the financial interest of a company that holds rights
to intellectual property for which the investigator or a Close Relation is the
inventor and the licensor is not the University;
·
Purchasing,
including subcontracting, from entities in which an investigator or Close
Relation has a financial interest.
·Any
other situation where the objectivity of an Investigator or the research could
reasonably be questioned.
3.2 Conflict of Commitment
The term "conflict of commitment" in this policy relates to an Investigator’s distribution of effort between his or her responsibilities to USC and his or her outside activities. For example, full-time faculty members are expected to devote their primary professional loyalty, time and energy to their teaching, research, service and clinical duties, as applicable. A conflict of commitment arises when outside activities interfere with the individual's obligations to USC. A conflict of commitment for purposes of this policy includes, but is not limited to:
Outside consulting activities by faculty members that exceed the permissible limits (i.e., an average of one day per week);
Any other situation where a full-time employee’s primary
professional loyalty in conducting his or her research is not to USC (e.g., a
full-time faculty member submits or routes a grant through another University
or institution)
3.3 Investigator
The term "Investigator" means the principal investigator, co-principal investigator, and any other person at the University who substantively is responsible for the design, conduct, and reporting of research activities, funded, proposed for funding, or unfunded.
3.4 Close Relation
The term "Close Relation" means spouse, mutual financial dependent, significant other, or person in an intimate relationship, child, parent, or sibling (including in-laws and step-relations), grandparent, grandchild, niece or nephew, aunt or uncle or cousin.
4.0 Principles
4.1 USC faculty members, staff and students are expected to avoid actual or apparent conflicts of interest and conflicts of commitment that directly and significantly affect USC's interests related to proposing, conducting or reporting research; or otherwise compromise the objectivity and/or performance in carrying out USC responsibilities related to research, unless such conflicts are managed in accordance with this policy.
4.2 Keys to preventing and resolving conflicting situations are full disclosure
followed by peer review,
close monitoring and conflict management. Full disclosure of relevant
information is in the best interest of the institution, the Investigator, and
his or her research staff members. It demonstrates good faith on the part of
the Investigator and protects his or her reputation and that of the University.
Disclosure will not necessarily restrict or preclude an individual's
activities.
4.3 It is the ultimate responsibility of each Investigator to
determine whether he or she or his or her Close Relation or any individual
involved in proposing, conducting or reporting research on his or her project
(e.g., research staff members, technicians, administrators, graduate
assistants) has an apparent or actual conflict of interest or commitment as
defined by this policy. It also is the responsibility of the Investigator to
ensure that any apparent or actual conflicts of interest or commitment as
defined by this policy of any of his or her research staff are disclosed and
managed pursuant to this policy. The
Investigator will be held responsible for failure to comply with this
policy. If in doubt concerning the possibility of a conflict arising from
outside interests and activities, Investigators should consult with the Vice
Provost for Research, the Office of Compliance or the Office of General Counsel
for guidance.
4.4 Prior to the expenditure of PHS or NSF
funded awards, the University must
report to the federal
awarding agency the existence of a financial conflict of interest and assure
that the conflict has been managed, reduced, or eliminated. Furthermore, if for any reason the
University finds it is unable to satisfactorily manage a conflict of interest,
then the federal funding agency will be informed promptly. The Vice Provost for Research or his or her
designee is responsible for these reports.
4.5 Failure to report a conflict of interest, or refusal to
cooperate in the management of a conflict of interest, constitutes misconduct
and may be cause for disciplinary action.
Possible violations of this policy include, but are not limited to,
refusal to file the disclosure form or furnishing false, misleading, or
incomplete information on the disclosure form.
Sanctions for violations of this policy can range from administrative
intervention to termination of employment or dismissal for cause, in accordance
with applicable University policies, which for faculty, are published in the
Faculty Handbook.
5.0 Procedure
5.1 Prior to commitment to a proposed external activity or
financial or business relationship relating to one's research, informal
discussion between the Investigator and the relevant Dean or Assistant Dean for
Research is strongly encouraged to promote mutual understanding and to
prevent avoidable conflicts from developing.
The Dean or Assistant Dean for Research is strongly encouraged to
discuss the matter with the Vice Provost for Research.
5.2 Prior to or contemporaneous with submitting a research
proposal,
Investigators must certify
with a "yes/no" declaration that they have read and understand this
policy and that they will comply with any conditions or restrictions imposed by
USC to manage, reduce or eliminate conflicts of interest. That certification
will be requested in the following documents:
(1) the Contracts and Grants Proposal Approval Record, which must be
completed for all sponsored projects submitted to the Department of Contracts
and Grants; (2) the Institutional Review Board initial and continuing review
applications; and (3) the Health Research Association form for non-government
funded projects conducted by Keck School of Medicine Investigators.
5.3 An Investigator who has a conflict
of interest or a conflict of commitment, as defined above, must complete a "Statement of Outside Interests Related
to Research," which discloses the apparent or actual conflict and
requests the information needed for the University to manage the conflict. The “Statement of Outside Interests Related
to Research” can be obtained from the Department of Contracts and Grants or
downloaded from its Web site at: www/usc/edu/dept/contracts.
5.4 During
the term of an award, if any new or previously undisclosed
conflicts
of interest arise, the "Statement of Outside Interests Related to
Research" disclosure statement to the University must be initiated or
updated, particularly if there is any significant change in personal, financial
or fiduciary status.
5.5 Once the "Statement of Outside
Interest Related to Research" form is completed, it must be submitted
promptly to the Vice Provost for Research for further action. Such submissions may be provided in a sealed
envelope marked, "Confidential."
Investigators should make disclosures directly to the Vice Provost for
Research for resolution, not to the sponsor.
Alternatively, the completed form also can be submitted to any of the
following departments, which will forward the information directly to the Vice
Provost for Research on the Investigator’s behalf:
Department of Contracts and Grants www.usc.edu/dept/contracts
Office of Compliance www.usc.edu/compliance
Assistant Dean of Research of the relevant school
5.6 The Disclosure Review Committee consists of faculty
members
appointed by the Provost's
office, along with Contracts and Grants and Technology Licensing Office staff (ex officio), an attorney from the Office
of General Counsel (ex officio) and
the Executive Director of the Office of Compliance (ex officio). A current
list of the committee members can be found at:
www.usc.edu/compliance. The Vice Provost for Research, or his or her
designee, shall chair the Disclosure Review Committee. At the request of the dean of a school, the
Provost’s office may, at its discretion, appoint a school specific Disclosure
Review Subcommittee, which may include members or non-members of the
University-level Disclosure Review Committee. The Disclosure Review Committee
will oversee the Subcommittee’s activities and will set deadlines for the
Subcommittee to report back with its findings.
5.7 The Vice Provost for Research or his or
her designee, shall present the
“Statement of Outside Interest Related to Research” to the members of the Disclosure Review Committee or Subcommittee for their consideration to determine whether a conflict of interest exists and, if so, to recommend to the Vice Provost for Research what conditions or restrictions should be imposed by the University to manage, reduce or eliminate such conflicts. The Vice Provost for Research may refer a Subcommittee recommendation to the University-level Disclosure Review Committee.
5.8 The Health Sciences Campus Institutional Review Board also has an important and legitimate role to play in determining if a conflict of interest in research exists regarding clinical research, and in determining if a proposed remedy is sufficient to protect research integrity and human participants. Accordingly, the Disclosure Review Committee may seek input and recommendations from the Institutional Review Board Chairperson or designee when determining how best to manage an actual or apparent conflict relating to research involving human subjects.
5.9 The Disclosure Review Committee or Subcommittee shall meet on a regular basis, as determined by the Vice Provost for Research. The Vice Provost for Research shall educate the members of the Disclosure Review Committee about the importance of confidentiality in its deliberations and will take reasonable steps to ensure the confidentiality of the information provided. Meetings will be closed for confidentiality reasons. However, investigators or other individuals with relevant information may be invited to discuss a particular project, as appropriate. Committee members who breach the confidentiality requirements will be sanctioned as appropriate, including removal from the Disclosure Review Committee.
5.10 Given the complexity of financial relationships within the University, disclosures of actual or apparent conflicts of interest will be handled by the Disclosure Review Committee on a case-by-case basis to determine whether a researcher’s financial or personal interests are related to University research and constitute a conflict of interest, and if so, how the conflict should be managed. Many conflicts can be managed, after an appropriate evaluation, in the following manners. Situations will be found to be:
·
Permitted
as is, because the disclosed personal information does not represent an
apparent or actual conflict of interest or other possible source of
unreasonable bias or inappropriate activity, or
·
Permitted
contingent upon the implementation of one or more committee recommendations, to
manage an apparent or actual conflict or otherwise preclude unreasonable levels
of bias or inappropriate activities, or
·
Unacceptable,
and thus prohibited.
5.11 Options for management of a conflict and a mechanism for reporting back to the Disclosure Review Committee or Subcommittee should be developed in each case. Possible options include, but are not limited to:
·
Public
disclosure of all relevant information, including disclosure when submitting
proposals, publications and manuscripts, making oral presentations or
presenting abstracts, or in the informed consent process when enrolling human
subjects in research,
·
Providing
copies to the Disclosure Review Committee of any financial or other disclosure
statements submitted to journal editors, conferences, etc.,.
·
Reformulation
of the research workplan,
·
Restrictions
on enrolling or obtaining informed consent from human participants,
·
Restrictions
on the analysis of data,
·
Close
monitoring of the research project by independent reviewers,
·
Divestiture
of relevant financial interests,
·
Creation
of escrow account to hold equity interests or intellectual property interests
that create an actual or apparent conflict of interest;
·
Restrictions
on the transfer or sale or equity or intellectual property interests,
·
Termination
or reduction of involvement in the relevant research project,
·
Termination
of inappropriate student involvement in projects,
·
Severance
of outside relationships that pose conflicts,
·
Removal
from the research project of an Investigator with an apparent or actual
conflict of interest,
·
Monitoring
and oversight by the Disclosure Review Committee or Subcommittee or by an
individual delegated to monitor by the Disclosure Review Committee. Any such Subcommittee or delegated
individual will report to the Disclosure Review Committee.
5.12
In some cases, the Disclosure Review
Committee or Subcommittee may
consider steps taken to minimize potential bias, and protective factors in the design of the study, such as multiple investigators, blinding, or objective endpoints.
5.13 In cases involving conflicts of commitment, the Disclosure Review Committee or Subcommittee shall seek input from the supervisor, Division Chief, Chair or Dean of the Investigator who has an apparent or actual conflict of commitment. The Investigator’s supervisor will be asked to assist the Disclosure Review Committee or Subcommittee in determining whether an actual or apparent conflict of commitment exists. It is expected that the Investigator’s supervisor would be in the best position to determine if the Investigator has been devoting the appropriate level of effort to his or her USC responsibilities. The Disclosure Review Committee also can refer a matter to the relevant Dean or Subcommittee for review and management at the school level.
5.14 The Disclosure Review Committee and Subcommittee will
make their recommendation to the Vice Provost for Research, who will make the
final determination regarding management of the conflict at issue, whether the
recommendation is made at the school-specific or University level. The Vice
Provost for Research will notify the individual who has the potential or actual
conflict in writing of the University's determination. The Vice Provost for Research also will
notify the relevant Investigator (if the Investigator is not the individual
making the disclosure) and, if appropriate, the relevant Dean. The Vice Provost for Research may notify
other individuals on campus, as appropriate, who have a “need to know,” (e.g., the HSC IRB Chairperson, the
Assistant Dean for Research or equivalent at the relevant school). All decisions must be documented.
5.15 In the event that a possible or apparent conflict of
interest is identified in connection with PHS or NSF funded awards, the Vice
Provost for Research, or his or her designee, will report to the federal
awarding agency the existence of a financial conflict of interest and assure
that the conflict has been managed, reduced, or eliminated. Furthermore, if for any reason the conflict
of interest cannot be managed satisfactorily, then the federal funding agency
will be informed promptly.
5.16 Violations that appear to have resulted in a misrepresentation
of research results will be handled according to the University’s policies for
dealing with allegations of misconduct in research, and other misconduct will
be handled under the procedures specified in the Faculty Handbook. Violations
of federal or state statutes and guidelines must be handled according to
federal and state laws and requirements.
5.17 A faculty member seeking review of the decision by the
Vice Provost for Research may do so by filing a grievance under the provisions
of the Faculty Handbook on any of the grounds on which a tenure decision may be
grieved. The decision of the Vice
Provost for Research will remain in full force and effect throughout the review
process.
5.18 Records relating to actual conflicts of interest and the determinations
of
the Disclosure Review
Committee will be kept by the Vice Provost for Research until three years after
the termination or completion of the project, whichever is later. The Vice Provost for Research will take
reasonable steps to protect the confidentiality of the information as well as
the recommendations for managing the actual or potential conflict. At the discretion of the Vice Provost for
Research, a Subcommittee may maintain certain records, as necessary, to assist
the Subcommittee in managing an actual or perceived conflict, provided the
Subcommittee has established appropriate safeguards to maintain confidentiality
of the records.
5.19 This policy does not preclude a Dean from requiring
Investigators in his or her school to provide additional conflict of interest
information or to do so on a more regular basis (e.g., annually).
5.20 Faculty, staff and students will receive guidance in interpreting this policy and education regarding situations to avoid that could lead to conflicts of interest and whom to consult when questions arise.
6.0 Disclosure
Review Committee Charges
When presented with the facts of a given situation, the Disclosure Review Committee must first determine if there is legitimate cause for concern over inappropriate behavior or the injection of undue bias into the professional activities of an Investigator or his or her staff. In order to make this determination, the Committee should inquire into the following:
·
Has
all relevant information concerning the individual's activities been acquired
(i.e., has there been full disclosure)?
·
If
the research at issue is a clinical trial, in what phase is the clinical
trial? What kind of intervention is
involved (therapeutic or non-therapeutic)?
·
If
equity interests are involved, is the equity held in a privately held or
publicly traded company? What is the
size of the company?
·
Is
the financial relationship with the entity fixed (e.g., fixed payment) or
variable (e.g., equity, stock options)?
·
What
influence, if any, does the individual have over the entity at issue?
·
Do
the individual's relevant financial or other interests exceed predetermined
thresholds of acceptability, where specified?
·
Do
the faculty member's reported external commitments exceed permissible levels?
·
Is
there any indication or perception that research results have not been
faithfully and accurately reported?
·
Is
there any indication or perception that the individual in his or her
professional role has improperly favored any outside entity or appears to have
incentive to do so?
·
Has
the individual inappropriately represented the University to outside entities?
·
Does
the individual appear to be subject to incentives (consulting payments, finders
fees, equity interests) that might lead to inappropriate bias?
·
Are
students or USC employees performing services for a company in which an
Investigator or Close Relation of an Investigator has an ownership interest or
from which he or she receives any type of remuneration?
·
Is
there any indication or perception that obligations to the University are not
being met?
·
Is
the individual involved in a situation similar to any of those described
earlier in the document that might raise questions of bias, self-dealing,
inappropriate use of University assets, poor management, or impropriety?
·
Could
the individual's circumstances suggest a violation of federal, state, or local
laws and requirements?
If as a result of this
inquiry, it appears that there may be an apparent or actual conflict of
interest, the Disclosure Review Committee must ascertain whether appropriate
management of the conflict is in place or could be implemented to address the
possible conflicts. In this case, the Disclosure Review Committee will
determine, as relevant, the following:
·
Will
the research workplan receive independent peer review prior to its initiation?
·
Will
the negotiation of relevant research affiliations or other contracts be handled
by truly disinterested representatives of the institution?
·
Are
there mechanisms in place to prevent the introduction of bias into research
projects (i.e., Is the protocol double-blinded? Are research subjects randomly
selected?)?
·
Will
the project be supervised by someone with authority and no conflicting
interests?
·
Are
there means to verify research results (e.g., independent corroboration in
another lab, FDA review)?
·
Will
data and materials be shared openly with independent researchers? If not, who
determines accessibility to such resources?
·
Will
the product of the collaborative effort with an outside party be published in
the peer-reviewed scientific literature?
·
Will
the sponsorship and relevant interests receive acknowledgment in public
presentations of the research results?
As a result of this inquiry, the Disclosure Review
Committee or Subcommittee will make a recommendation to the Vice Provost for
Research regarding the appropriate manner of addressing any real or apparent
conflicts of interest, and will communicate such to the relevant Investigator.
7.0 Resources
Objectivity in Research -
NIH Guide
http://grants.nih.gov/grants/guide/notice-files/not95-179.html
http://www.nsf.gov:80/bfa/cpo/gpm95/ch5.htm#ch5-6
OHRP Draft Interim Guidance - Financial
Relationships in Clinical Research:
Issues for Institutions, Clinical Investigators and IRBs to Consider
When Dealing with Issues of Financial Interest and Human Subject Protection
http://ohrp.osophs.dhhs.gov/nhrpac/mtg12-00/finguid.htm
American Society of Gene Therapy - Policy Position
Statement
http://www.asgt.org/policy/index.html
AAMC Guidelines for Dealing with Faculty Conflicts
of Commitment and Conflicts of Interest in Research
http://www.aamc.org/research/dbr/coi.htm
Food and Drugs:
Financial Disclosure by Clinical Investigators
http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfr54_01.html
USC Purchasing Policy – Conflict of Interest
http://www.usc.edu/bus-affairs/admin_serv/purchasing/policies.html#conflict
USC Conflict of Interest Policy
http://www.usc.edu/policies
http://www.aau.edu
Harvard University:
Policy on Conflicts of Interest and Commitment
http://www.hms.harvard.edu/integrity/conf.html